LDL-Cholesterol Lowering Effect of KB2115 as Add on to Statin

Inclusion criteria

• Signed informed consent
• Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following:

• Non-nursing and non-pregnant 12 months prior to enrolment
• Not of child bearing potential ie, either documented irreversible surgically sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal ligation) or post-menopausal. Post-menopausal is defined as serum follicle-stimulating hormone (FSH) levels in the post-menopausal range combined with amenorrhea for more than 1 year in a woman above 50 years of age, or amenorrhea for more than 2 years below 50 years of age
• Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization

• Atorvastatin not more than 20 mg/day or
• Simvastatin not more than 40 mg/day
• LDL-cholesterol > 3.0 mmol/L (Week -1)
• Subject able and willing to comply with all study requirements
• At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study

Exclusion criteria

• Cholesterol lowering agents other than the defined statins
• History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
• Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator
• Chronic (> 3 months) pain condition requiring daily medication with pain killers
• Glycosylated haemoglobin (HbA1c) > 7.0%
• Diabetes requiring medication other than metformin
• Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting ECG, eg, QTc interval > 450 msec
• Body Mass Index of ≥ 40 kg/m2
• Resent history (< 3 month) of stroke or transient ischemic attacks
• History of seizure disorder, except febrile convulsions
• A current diagnosis of cancer, unless in remission
• Blood pressure (BP) of > 160/95 mm Hg
• History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia and atrial fibrillation
• Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or percutaneous coronary intervention < 6 month before randomization
• Congestive heart failure New York Heart Association Class > 2
• Unstable or severe angina pectoris or peripheral artery disease
• Known thyroid disease or thyroid biomarkers (TSH, T3, free T3, T4, free T4) outside reference range for normal at enrolment and at baseline
• Positive urine pregnancy test in women at enrolment
• Use of thyroid replacement therapy and hormone replacement therapy (including contraceptive pills) for last 3 months before randomization